Field of the Disclosure
The present disclosure is directed to a wearable electrode for the delivery of therapeutic electrical current, using such an electrode, where the electrode is both breathable and waterproof, and with the conductive properties to be able to support the efficacious delivery of high current electrical therapy.
Description of Related Art
Cardiac arrhythmias, such as ventricular fibrillation and ventricular tachycardia, are electrical malfunctions of the heart, in which regular electrical impulses in the heart are replaced by irregular, rapid impulses. These irregular, rapid impulses can cause the heart to stop normal contractions, thereby interrupting blood flow therethrough. Such an interruption in blood flow can cause organ damage or even death.
Normal heart contractions, and thus normal blood flow, can be restored to a patient through application of electric shock. This procedure, which is called defibrillation, has proven highly effective at treating patients with cardiac arrhythmias, provided that it is administered within minutes of the arrhythmia. Portable, wearable defibrillator systems have been developed which monitor a patient's cardiac activity, detect arrhythmias, and provide defibrillation electric shocks to restore normal heart contractions and blood flow.
Various other pathophysiological conditions may also be treated by the delivery of therapeutic electrical current to physiologic tissues such as the myocardium, nerves, or skeletal muscles using such methods as transthoracic cardiac pacing (TCP).
In the current state of the art, a so-called “dry” therapeutic electrode may be employed where the conductive gel is stored and then deployed via electronically-activated gas pressure, much like an air-bag in a car, such as is manufactured by ZOLL Medical Corporation, Pittsburgh Pa. In this case, separate electrocardiogram (ECG) monitoring electrodes are used.
Alternatively, self-adhesive electrodes such as are used on conventional, non-wearable defibrillators may be employed. In this case, the electrodes are capable of performing both the functions of ECG monitoring and defibrillation. The self-adhesive defibrillator electrodes of these systems can be large, e.g., 2-8 inches in diameter, and use vapor impermeable materials such as metal foils, hydrophilic, water saturated conductive hydrogels, and electrically insulating layers that prevent the patient's expired vapor from the skin surface from evaporating, eventually softening the epidermis and resulting in degradation of the structural integrity of the skin leading to sloughing and peeling of the skin when the electrode is removed after extended wear. As a result, the patient's skin may become irritated which can lead to the patient being non-compliant with his/her treatment when he/she refuses to or can no longer wear the electrodes.
Also, the materials from which these electrodes are made and the adhesives that are used are not waterproof during bathing or showering and do not conform well to the patient's body or movement. This results in the electrodes having to be replaced frequently, often on a daily basis.
Thus, there is a need for an electrode that is less irritating to the patient's skin that remains adhered to the patient's skin for a longer time period, for example, as long as two weeks. A vapor permeable self-adhesive wearable electrical therapy electrode would be desirable over the current art for reducing thickness and weight while at the same time increasing patient comfort and increasing the duration of continuous electrode wear.